Teva Pharmaceuticals recalled 7,448 bottles of Metoprolol Succinate Extended-Release Tablets nationwide after failed dissolution specifications were identified. The recall involves 100 mg, 100‑tablet bottles (NDC 45963-677-11) and 1,000‑tablet bottles (NDC 45963-677-96). The defect may affect drug release and efficacy. Patients should stop using affected bottles and contact Teva or their clinician
Failed Dissolution Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
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NDCs: 45963-677-11 (100 mg, 100-tablet bottles) and 45963-677-96 (1000-tablet bottles). Distribution: Nationwide. Quantity: 7,448 bottles. Sold as Rx Only. Brand: METOPROLOL SUCCINATE. Manufacturer: Teva Pharmaceuticals USA, Parsippany, NJ 07054.
The product has failed dissolution specifications. The failure can lead to inaccurate release of the active drug, potentially reducing therapeutic effect or causing variable drug levels in patients.
1 Stop using the product immediately. 2 Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. 3 Monitor for changes in blood pressure or heart rate and report any concerns to your clinician.
Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054. For guidance, refer to the FDA enforcement report D-0356-2026 and Teva’s recall communications.
Not sure what to do next? Our guide walks you through the process step by step.
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